Heart Failure
Conditions
Brief summary
The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.
Interventions
DIAGNOSTIC_TESTPeripheral arterial tonometry (PAT)
Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI)
PROCEDURESubcutaneous adipose tissue collection
During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)\<35%, Left Bundle Branch Block (LBBB)\>120 ms, New York Heart Association (NYHA) Class II-III). * Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks
Exclusion criteria
* Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vascular endothelial function | baseline, 3 months | Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months. |
Countries
United States
Outcome results
None listed